A Look at the REACH Evaluation Process for Dossiers and Substances

• April 23, 2021

Focused largely on making certain that the proper information is present and accessible for chemicals made available in the European Union, the evaluation process is a key component of REACH. Here we present a brief overview of the evaluation process for dossiers and substances.

Evaluation Process

As outlined by the European Chemicals Agency (ECHA), the evaluation process for dossiers and substances includes several key phases:

• Phase 1: Assessment
• Phase 2: Decision Making
• Phase 3: Decision Follow-up

Phase 1 – General Steps

• Dossier Evaluation
  • Dossier evaluation aims to ensure that information required by REACH is present in the dossier or included in a testing proposal. Evaluation encompasses compliance checks and testing proposal examination.
  • A key purpose of compliance checks is to see that REACH information requirements are met.
    • If the ECHA determines additional information is needed, a request is sent by the Agency to registrants.
    • If the ECHA determines additional information is not needed, no action is taken toward registrants.
  • For registrants that conduct any new test listed in Annexes IX and X to REACH, submission of a testing proposal is required.
• Substance Evaluation
  • Substance evaluation is intended to assess whether risk to human health or the environment is posed by a chemical substance of concern (as identified by the ECHA and Member States).
  • Evaluation is conducted only on chemical substances registered under REACH.
    • If evaluation determines additional information is necessary to clarify the concern, a request is sent to registrants by the corresponding evaluating Member State competent authority (eMSCA).
    • If evaluation determines additional information is not necessary, a conclusion is issued by the eMSCA.

Phase 2 – General Steps

• Draft decision is prepared by the ECHA or eMSCA; 30 days are allowed for the provision of corresponding comments and related information from registrants.
  • Depending on comments received, the ECHA may amend the draft decision.
• All Member States must agree upon the decision prepared by the ECHA; Competent authorities of the Member States must propose any amendments within 30 days.
  • If amendments are proposed, the decision must be sent to the Member States Committee.
  • If no amendments are proposed, the decision will be adopted by the ECHA.
• Member State Committee evaluates whether amendments should be made to the decision; Unanimous agreement must be reached within 60 days.
  • If there is unanimous agreement, the decision is adopted by the ECHA.
  • If there is not unanimous agreement, the matter is referred to the European Commission.

Phase 3 – General Steps

• Dossier Evaluation Decision Follow Up
  • Follow-up to dossier evaluation occurs after the deadline for registration dossier updating has occurred; ECHA conducts assessment to determine if necessary requested information has been received.
    • If information requirements have been satisfied, relevant parties (including the European Commission, Member State competent authorities, and registrants) are made aware by the ECHA that evaluation has been concluded.
    • If information requirements have not been satisfied by registrants, Member States and other relevant parties are notified.
• Substance Evaluation Decision Follow Up
  • Follow-up to substance evaluation occurs after the deadline for dossier updating has occurred, or after it has been determined that all requested information has been received.
  • If a registrant provides updated dossier information, the eMSCA is notified by the ECHA; eMSCA verifies that this new information aligns with the ECHA’s requirements and that there has been clarification of the concern.
    • If the concern has been clarified and addressed by the information provided, a conclusion is issued by the eMSCA.
    • If the concern has not been clarified and addressed by the information provided, a notification is issued by the eMSCA to the ECHA.

More detailed information on REACH evaluation and the steps involved in the evaluation process may be found on the ECHA website.

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